Pharmacologic class (EPC) · 3 drug pages

Human alpha-1 proteinase inhibitor: adverse event reports filed with FDA

4,163 reports list a drug in this class as a suspect or interacting product, 2011–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

4,163
reports across the class: 0% of all reports; 631
reports, 12 months to June 2026: 760 in the 12 months before; 60.1%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Human alpha-1 proteinase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 4,163 adverse event reports received by FDA, 0% of the database, from April 2011 to June 2026.

631 reports arrived in the 12 months to June 2026, down 17% from 760 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 60.1% of the class's reports are marked serious, 11.3% record death among the outcomes and 31.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are dyspnoea (15.6%), pneumonia (13.1%) and fatigue (11.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
GlassiaAlpha.1-proteinase inhibitor human	brand	2,273	267	74.7%	Dyspnoea
Prolastin-C LiquidAlpha1-proteinase inhibitor (human)	brand	1,300	192	20.8%	Fatigue
Alpha.1-proteinase inhibitor human	generic	590	172	90.2%	Pneumonia

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Dyspnoeashortness of breath15.6%648
Pneumonialung infection13.1%546
Fatiguetiredness11.5%478
Headachehead pain10.2%424
Product dose omission issuea dose was missed10.1%421
Deaththe patient died; cause not stated by this term8%334
Coughcough7.8%324
Inappropriate schedule of product administrationthe product was taken at the wrong times7.3%304
Malaisegeneral feeling of being unwell6.4%267
Covid-19COVID-19 infection5.8%242
Nauseafeeling sick5.6%233
Falla fall5.3%222
Dizzinesslight-headedness or unsteadiness5%210
Blood pressure increaseda raised blood pressure reading5%208
Nasopharyngitisa cold4.8%198
Painpain, site not specified4.7%197
Diarrhoealoose or frequent stools4.6%193
Insurance issue4.6%193
Productive cougha cough with phlegm4.3%177
Sinusitissinus infection4%168
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease3.9%164
Bronchitischest infection3.8%160
Oxygen saturation decreased3.8%158
Respiratory tract infectiona respiratory infection3.7%156
Pyrexiafever3.7%155

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death11.3%471

Life-threatening1.1%44

Hospitalisation (initial or prolonged)31.9%1,326

Disability0.3%14

Congenital anomaly0%2

Other serious40.6%1,690

Not serious39.9%1,663

Patient age

Under 20%0

2 to 110.1%3

12 to 170%2

18 to 444.3%178

45 to 6424.2%1,009

65 to 7416.3%678

75 and over7.9%327

Age not given47.2%1,966

Who reported

Physician5.6%232

Pharmacist3.2%133

Other health professional25%1,042

Lawyer0%0

Consumer or non-health professional65.4%2,722

Not given0.8%34

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Human alpha-1 proteinase inhibitor reports

Which drugs are in the Human alpha-1 proteinase inhibitor class on this site?

Glassia, Prolastin-C Liquid and Alpha.1-proteinase inhibitor human. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

4,163 reports through June 2026, 631 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

dyspnoea (15.6%), pneumonia (13.1%), fatigue (11.5%), headache (10.2%) and product dose omission issue (10.1%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.